Issues Abound Tracking Efficacy And Effectiveness In Clinical Trials

A recent assessment of characteristics of the clinical trials recorded in the US-based registry ClinicalTrials.gov raises questions about the best methods for generating evidence as well as the capacity of clinical trials to supply sufficient amounts of high quality evidence needed to ensure confidence in guideline recommendations. Now armed with this increased level of data from the registry, the study’s authors conclude that the desire to provide high quality evidence for medical decisions must include consideration of a comprehensive redesign of the clinical trials enterprise. That these issues hold for interventional trials suggests that other strands of clinical research, notably those focused on comparative effectiveness, face similar if not even greater challenges to be able to provide meaningful real-world evidence.

“We now have the ability to comprehensively look at the [clinical trials] system, which has never existed before,” says Robert Califf, MD, director of the Duke Translational Medicine Institute...